Kornimate/medical-research-clean huggingface dataset:
second canadian trial of physiologic pacing (ctopp ii): pilot trial

Conditions: Pacemaker Dependence

Summary: pacemaker therapy has been recognized as effective for the control of sinus and atrio-ventricular (av) node dysfunction. single chamber pacing when compared with dual chamber pacing, has numerous advantages of low complication rates, lower cost, better longevity, with non-inferiority in the quality of life and hard outcomes proven in direct randomized comparisons. however, comparison between single and dual chamber pacers was never adequate, since not more then half of the patients in the trials were actually using pacemakers for the majority of the time. routine dual chamber pacing using a right ventricle apical lead is also associated with significant increase in peri-operative and remote complications. some of these complications may be related to ventricular desynchronization secondary to the pacing location, which is potentially avoidable by using biventricular pacing. a randomized trial which will compare single chamber rate responsive pacing to the best available modification of dual chamber pacing (biventricular pacing) in suitable patients is therefore warranted.


Eligibility criteria:
inclusion criteria: * patient has symptomatic bradycardia and is a candidate for first pacemaker implantation * patient has high risk of being pacemaker dependent by (at least one of the following): 1. average heart rate of 60 or less on pre-implant holter 2. maximal heart rate of 60 in patient on telemetry monitoring 12 hrs preoperatively, when not under medications decreasing heart rate, or under chronic medical treatment inducing bradycardia, which is unlikely to be changed 3. first degree av block with pr intervals \> 300 ms, or second degree av block at heart rates \<= 80 bpm. 4. dependence for 12 hrs when on temporary pacemaker set at 50 bpm if bradycardia is not secondary to medication, or under chronic medical treatment inducing bradycardia, which is unlikely to be changed. exclusion criteria: * age \<= 65 years * chronic atrial fibrillation * indication for icd * non-cardiovascular death is likely to occur within 3 years * geographical, social, or psychiatric reasons making follow-up problematic

Keywords: pacemakers atrial fibrillation stroke cardiovascular death
guided feedback in an online game impacts decision making

Conditions: Depressive Symptoms

Summary: the purpose of the study is to evaluate the use of a text-based game as a way to understand decision making and knowledge related to anxiety, stress, and mood states like depression or loneliness. the investigators are interested in identifying whether participants who are given feedback before and during the game will report changes in behavior or depressive symptoms over the course of a one-week period. this is a follow-up to the published study from the researchers.


Eligibility criteria:
inclusion criteria: * 18+ age * eligible to participate in online research * able to read and respond in english exclusion criteria: * none

Keywords: depressive symptoms
sequential administration of fe75c and docetaxel versus docetaxel/cyclophosphamide in her-2 negative, node positive breast cancer

Conditions: Breast Cancer

Summary: in this trial investigators propose to assess the dose dense, g-csf supported sequential administration of 4 cycles of fec followed by 4 cycles of docetaxel versus 6 cycles of docetaxel/cyclophosphamide as adjuvant chemotherapy in women with her-2 negative, axillary lymph node positive breast cancer

anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. at least five large randomized clinical trials demonstrated that the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an anthracycline-based regimen resulted in superior clinical outcome for women with node positive or high risk node-negative early breast cancer. in two large randomized studies the dose dense administration with g-csf support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. in one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. data from at least one trial suggest that four cycles of a non-anthracycline but taxane-containing adjuvant regimen (docetaxel plus cyclophosphamide) provide outcomes that are at least as good, if not better than four cycles of doxorubicin/cyclophosphamide combination.

Eligibility criteria:
inclusion criteria: * women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma * within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed. * tumor involvement of at least one axillary lymph node * absence of any clinical or radiological evidence of local or metastatic disease * premenopausal or postmenopausal women aged 18-75 years old * adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3) * adequate liver (bilirubin \<1.0 times upper limit of normal and sgot/sgpt \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl) * adequate cardiac function (lvef\>50%) * written informed consent exclusion criteria: * positive pregnancy test. * psychiatric illness or social situation that would preclude study compliance. * other concurrent uncontrolled illness. * prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents. * previous history of other invasive malignancy other than non-melanomatous skin cancer.

Keywords: early breast cancer axillary node positive her-2 negative adjuvant chemotherapy dose dense docetaxel fec
drug utilisation of mysimba/contrave

Conditions: Obesity

Summary: this study will assess a retrospective cohort of users of mysimba/contrave with up to 548 days (\~18 months) after initiation with treatment with mysimba/contrave. this study will describe mysimba/contrave utilisation and incidence of aesis for users compliant and non-compliant with the smpc.


Eligibility criteria:
inclusion criteria: * at least one prescription of mysimba/contrave in his/her medical records any time during the study period (us) or at least one dispensing of mysimba/contrave in his/her registry any time during the study period (nordic); * at least 365 days of computerized records prior to first mysimba/contrave prescription or dispensing date; and3patient is active (i.e., alive and registered/accruing data) at the time of the first mysimba/contrave prescription or dispensing date. exclusion criteria: - all patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
persistent postpartum hypertension pilot trial

Conditions: Hypertension in Pregnancy

Summary: this study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. the purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. there are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.

study groups will include a treatment with nifedipine extended release or no treatment. subjects will be randomized 1:1. subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. the control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum. subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. medication compliance in the treatment group will be assessed via validated questionnaire. the primary outcome of this study is average systolic blood pressure at 1 week postpartum. patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.

Eligibility criteria:
inclusion criteria: * antepartum diagnosis of gestational hypertension * preeclampsia * superimposed preeclampsia without antepartum chronic hypertension medication * delivery at 23 weeks or greater * persistent elevation in bp \>24 hours postpartum (\>140/90 mm hg) (2 or more bp \>4 hours apart) * 18 years or older * english speaking exclusion criteria: * need for continuation of antepartum antihypertensive medication * contraindication of calcium channel blocker use * severe range (160/110 mm hg) blood pressure requiring treatment \>24 hours after delivery * requires a 2nd oral antihypertensive medication for blood pressure control inpatient * acute cardiomyopathy or heart failure * creatinine ≥1.5 * blood pressure \<90/60 within 24 hours of discharge
study on the significance of auricular clip in prevention and treatment of valvular heart disease atrial thrombosis

Conditions: Atrial Fibrillation; Thrombus; Embolism; Warfarin; Atrial Appendage; Surgery

Summary: to evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of warfarin's anticoagulant model were verified by the specimen library

atrial fibrillation (af) is a common arrhythmia. the risk of ischemic stroke in af patients is 4-5 times higher than that in non-af patients, and leads to nearly 20% mortality and nearly 60% disability. atrial fibrillation is associated with valvular disease and atrial fibrillation in about 30-70% of patients with valvular heart disease. left atrial thrombus occurs in 15-25% of patients with atrial fibrillation. more than 90% of patients with atrial thrombus is located in the left atrial appendage. in patients with valvular atrial fibrillation, the left atrial appendage is clamped at the same time of valvular surgery to avoid recurrence of atrial thrombus-related stroke. in this clinical trial, the left atrial appendage was used to clamp the prethrombotic site of the heart to prevent stroke and improve the prognosis.

Eligibility criteria:
inclusion criteria: 1. patients with valvular heart disease aged between 18 and 75 2. valvular heart disease \[cardiovascular surgery volume, clinical diagnosis and treatment guidelines, chinese medical association (2011 edition)\] 3. preoperative cardiac function grade ii-iii (nyha), no operation-related contraindications 4. understand the nature of this study, agree to participate in all terms of this study, sign informed consent, agree to accept postoperative treatment plan and follow-up requirements, and cooperate to complete follow-up exclusion criteria: 1. patients whose left atrial appendage has been resected or occluded 2. she had a history of open heart surgery with extensive adhesion of the pericardium 3. patients cannot be returned due to other reasons 4. failed to reach the end point in clinical trials of other drugs or devices 5. x-ray is contraindicated or not suitable for tee examination 6. those who are considered unsuitable for the clinical trial by the investigator
effectiveness of intelligent rehabilitation robot training system combined with repetitive facilitative exercise on upper limb motor function after stroke: a randomized control trial.

Conditions: Stroke

Summary: the goal of this clinical trial is to learn if intelligent rehabilitation robot training system combined with repetitive facilitative exercise (rfe) work to treat stroke in adults. the main questions it aims to answer are: does drug intelligent rehabilitation robot training system combined with rfe improve the upper limb motor function of participants? can the combination of intelligent rehabilitation robot training system and rfe achieve better effects? researchers will compare 3 groups (rfe, intelligent rehabilitation robot training system under rfe, and conventional therapy) to see if intelligent rehabilitation robot training system and rfe works to treat stroke. participants will: receive treatment for 4 weeks receive scale and instrument testing before and after treatment


Eligibility criteria:
inclusion criteria: * patients (18 to 74 years old) who suffered a first or second unilateral stroke * chronic stroke (over 6 months from the onset) * obvious upper limb movement disorders (fma-ue scores from 25 to 42) * ability to understand and follow simple directions exclusion criteria: * pregnant or lactating * upper extremity contracture, pain, or trauma * perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions * unable to maintain sitting posture * cerebellar lesion * clinically unstable medical disorders * inability to provide informed consent
a study to evaluate safety, pharmacokinetic, and biological activity of incb059872 in subjects with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this study was to evaluate the safety and tolerability, and the pharmacokinetic and biologic activity of incb059872 in participants with sickle cell disease.


Eligibility criteria:
inclusion criteria: * diagnosis of scd (sickle cell ss) confirmed through hemoglobin electrophoresis. * must be red blood cell (rbc) transfusion-independent (not currently on regularly scheduled transfusions) for ≥ 3 months from the time of first dose of study drug. * no rbc transfusion within 30 days of first dose of study drug. * hydroxyurea (hu) refractory -must not have received hu therapy during the 3 months before receiving study drug. * creatinine clearance ≥ 60 ml/min based on the institutional formula. * willingness to avoid pregnancy or fathering children. exclusion criteria: * any unresolved toxicity ≥ grade 2 from previous therapy except for stable chronic toxicities not expected to resolve. * pregnant or nursing women or participants expecting to conceive or father children within the projected duration of the study, starting with screening visit through completion of safety follow-up. * received an investigational study drug within 28 days or 5 half-lives (whichever is longer) before receiving the first dose of study drug (requirement may be waived with medical monitor approval). * chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. * prior receipt of lsd1 inhibitor therapy for any indication.

Keywords: sickle cell disease (scd) sickle cell ss lysine demethylase 1 (lsd1) inhibition
a clinical trial to evaluate the safety, tolerability and preliminary effectiveness of single administration intradiscal rhgdf-5 for the treatment of early stage lumbar disc degeneration

Conditions: Early Lumbar Disc Degeneration

Summary: study to show the safety, tolerability and preliminary effectiveness of intradiscal rhgdf-5 in subjects with early lumbar disc degeneration.


Eligibility criteria:
inclusion criteria: 1. persistent low back pain with at least 3 months of non-surgical therapy at one or two suspected symptomatic lumbar levels (l3/l4 to l5/s1) a. the recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of mri, ct and/or technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury). 2. oswestry disability index (odi) for low back pain of 30 or greater 3. low back pain score greater than or equal to 4 cm as measured by visual analog scale (vas) at visit 1 baseline 4. male or female 18 years of age or older exclusion criteria: 1. persons unable to have an mri 2. abnormal neurological exam at baseline (e.g., chronic radiculopathy) 3. persons with neurological or radiographic evidence of active radicular pain due to anatomical compression such as stenosis or disc herniation (persons with somatic referred pain are allowed) 4. suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments 5. suspected symptomatic sacro-iliac joint
effects of relaxing breathing combined with biofeedback on the performance and stress of residents during hfs

Conditions: Stress, Psychological; Stress, Physiological; Performance Anxiety; Critical Incident

Summary: the harmful effects of stress on health professionals are expressed both in terms of their health (physical or mental) and the quality of work (reduced memory capacity, deterioration in patient care). these adverse effects highlight the importance of implementing effective coping strategies and/or early learning of stress management methods in medical training programs. relaxation breathing techniques coupled with heart rate variability (hrv) biofeedback is one of the new techniques used to reduce the stress level. no research has yet tested the effects of hrv induced by relaxation breathing technique before managing a simulated critical situation.

this is a randomized, controlled study conducted at the university simulation centre in healthcare of lyon, france. the high-fidelity simulation (hfs) will be used as a research tool and the topics included will be the hfs residents summoned to critical care situations as part of their training curriculum. the study has received prior approval from the ucbl1. ethics committee. after information (protocol and objective of the study), signature of consent, and one minute of relaxing breathing training, the residents as active participants in hfs, will be included in the study. they will be equipped with hexoskin® jackets collecting heart rate, heart rate variability, breathing rate continuously and an empathica® connected watch for continuous measurement of electrodermal activity. then each resident will be randomized into one of the three intervention groups that are: * a relaxing breathing exercise coupled with biofeedback * a breathing exercise without biofeedback * a control occupation (observation of normal biological results). each intervention will last five minutes and will be conducted between the briefing and the scenario. main objective : the objective of this study is to compare during hfs, the performance of residents during critical care scenarios. the performance analysis will be performed by two independent and blinded evaluators, based on the video recordings of scenarios. the overall performance will be the addition of technical skills (specific rating grid for each scenario on 100 pts) and non-technical skills assessed by the ottawa grs grid (adjusted to 100 pts). secondary objectives : * compare the effects of the three interventions on reducing psychological stress. * compare the effects of the three interventions on reducing physiological stress. * compare the effects of the three interventions on increasing cardiac coherence scores.

Eligibility criteria:
inclusion criteria: * adult person * registered in specialized diploma of medical training. * invited for a high-fidelity simulation session at the lyon university simulation center. * have signed an informed consent form. exclusion criteria: * pregnant woman

Keywords: medical education simulated critical situation stress management and performance
hockey fans in training (hockey fit): a pilot pragmatic randomized controlled trial

Conditions: Overweight; Obesity

Summary: the hockey fans in training (hockey fit) program aims to improve overweight men's physical fitness, eating habits and health-related lifestyle choices through a lifestyle modification program in collaboration with two ontario hockey league teams. in this pilot pragmatic randomized controlled trial, the investigators plan to explore the potential for hockey fit to reduce a clinically important amount of weight, increase physical activity levels, and lead to improvements in other health-related outcomes.

in the united kingdom, the football fans in training (ffit) program was developed to encourage men to lead a healthier lifestyle through a sport-related medium. ffit is a gender-sensitized, weight loss and healthy living program developed for delivery to overweight and obese men through professional football clubs. published results from ffit show that the program was able to actively recruit and engage men and for the men who participated, sustained weight loss and positive lifestyle change was observed (hunt et al., 2014). this study will use a two-arm, pilot pragmatic randomized controlled trial (rct) design. the investigators will conduct the study in conjunction with two ontario junior a hockey clubs. following assessment of eligibility and baseline measurements, men will be individually randomized (1:1; stratified by club) to either the intervention group (receiving the hockey fit program) or to the comparison group (usual care wait-list control). the comparison group will be offered to start the hockey fit program after a 12-week delay. all men (both intervention and comparison groups) will receive publicly available healthy eating and physical activity materials at baseline. measurements will be taken at baseline and 12 weeks (both groups) and again at 12 months (intervention group only). the results of this study will be used to inform a fully-powered rct where the primary objective will be to determine whether, compared to the usual care wait-list control group, the hockey fit group will lose weight (at least 5% weight loss from baseline) at 12 months.

Eligibility criteria:
inclusion criteria: * objectively-measured body-mass index of at least 28 kg/m2 * clear physical activity readiness questionnaire (par-q) (i.e., either by answering "no" to all questions or receiving clearance from a health care provider) exclusion criteria: * unable to comprehend letter of information and consent documentation

Keywords: chronic disease lifestyle intervention health promotion sport mentorship men health technology prevention exercise diet